The Decree provides supplements to a lot of regulations on management of medical equipment as follows:
- All certificates of completion of training in classification of medical equipment which were granted before December 31, 2018 are valid for 3 years since the signature date;
- Holders of marketing authorization numbers of marketing authorization certificates must review results of classification of medical equipment and report to the Ministry of Health prior to July 1, 2019;
- ASEAN Common Submission Dossier Template takes effect from July 1, 2020.
In addition, the Decree adds regulations that stipulate the quick issue of new marketing authorization numbers for medical equipment in the following cases:
- Medical equipment has been granted marketing authorization in at least 02 countries including: Japan, Canada, Australia, United States and other EU states;
- Medical equipment must be granted marketing authorization ahead of December 31, 2018 and must meet the following requirements:
+ Medical equipment has been circulated for at least 03 years within the validity period of 05 years till the date of submission;
+ There is none of warnings about quality and safety of such medical equipment.
For more details, see the Decree No. 169/2018/ND-CP in force from December 31, 2018.
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